Actively Recruiting
Hepatic and Splenic Elastography to Predict Hepatocellular Carcinoma Recurrence Risk After Radiofrequency Ablation
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-15
50
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the link between hepatic and splenic elastography values and the chance of hepatocellular carcinoma (HCC) coming back after treatment with radiofrequency ablation (RFA). The study also aims to explore whether these elastography values relate to overall survival, HCC-specific survival, and the risk of liver decompensation after RFA. Additionally, the study will assess if non-invasive biochemical tests are connected to the risk of HCC recurrence. The participants are patients with liver disease and HCC who are candidates for RFA treatment and are referred to specialized gastroenterology centers in Italy. The study involves measuring liver and spleen stiffness using transient elastography or the ARFI method before or after RFA treatment. These procedures help assess tissue characteristics without invasive methods. Patients will undergo standard RFA treatment for their HCC according to the Barcelona Clinic Liver Cancer classification system. The focus is on evaluating elastography values in relation to clinical outcomes over time. Participants will be followed for 12 months to observe if HCC returns after RFA treatment. During this time, researchers will monitor elastography results, clinical status, survival, and liver function. Data from biochemical tests will also be collected to understand their association with recurrence risk. The study aims to improve understanding of HCC prognosis and help guide future management strategies for patients treated with RFA.
CONDITIONS
Official Title
Can Hepatic-splenic Elastography Predict the Risk of Hepatocellular Recurrence After Radiofrequency Ablation?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical-instrumental diagnosis of chronic liver disease
- Indication for treatment of HCC with radiofrequency ablation using the Barcelona Clinic Liver Cancer (BCLC) staging system
- Undergoing hepatic or splenic elastography by transient method with Fibroscan or ARFI method
- Signed informed consent
You will not qualify if you...
- Age under 18 years
- Diagnosis of hepatocholangiocarcinoma or other liver lesions besides hepatocellular carcinoma
- History of liver transplantation or liver resection for HCC in the previous two years
- Liver disease in decompensation (Child-Pugh C) at consent or within three months before enrollment
- Severe advanced diseases affecting short-term survival, such as non-remission cancers, severe heart failure (NYHA III or higher), dialysis-dependent chronic kidney failure, or lung diseases requiring home oxygen therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
R
Rocco Maurizio Zagari, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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